vTv Therapeutics Announces 2022 First Quarter Financial Results and Provides Corporate Update - Form 8-K

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Strategic Focus. We are prioritizing the development of our lead program TTP399, a novel, oral liver selective glucokinase activator, as a potential treatment for patients with type 1 diabetes ("T1D"), as well as continuing to support our currently partnered programs. Given the strategic focus on these programs, we have paused our development activities in the United States on HPP737 while we evaluate strategic options for it. As part of this planned strategic focus, the Company has reduced its workforce. We are actively seeking to raise capital through licensing TTP399 in regions outside of North America and Europe and are also actively seeking licensing deals for HPP737 and other assets. We are currently in active discussions with respect to financing, partnering, and licensing transactions for the further development of TTP399.

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Mechanistic Study of Ketoacidosis with TTP399. In October 2021, we announced positive results from the Mechanistic study indicating no increased risk of ketoacidosis with TTP399 during acute insulin withdrawal in patients with T1D. Patients with type 1 diabetes taking TTP399 experienced no increase in ketone levels relative to placebo during a period of acute insulin withdrawal, indicating that treatment with TTP399 presents no increased risk of ketoacidosis. In addition, patients taking TTP399 had improved fasting plasma glucose levels and experienced fewer hypoglycemic events relative to those taking placebo, consistent and supportive of the previously announced phase 2 Simplici-T1 Study results. Full study results will be published in the Diabetes Obesity and Metabolism journal in conjunction with the 82^nd American Diabetes Association Scientific Sessions on June 6^th, 2022.

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Pivotal Study Planning. The Company is planning two pivotal, placebo-controlled clinical trials of TTP399 in subjects withT1D and has engaged with the Food and Drug Administration ("FDA") on the optimal clinical trial designs for these studies. The studies will recruit a total of approximately 1000 patients and at least one of the studies will be one year of treatment. The FDA and the company have agreed on the primary endpoint for the studies as the difference between placebo and TTP399-treated group in number of hypoglycemia events. These pivotal studies are expected to start in 3Q 2022.

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Cash Position: The Company's cash position as of March 31, 2022, was $12.1 million compared to $13.4 million as of December 31, 2021.

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Revenue: Revenue in first quarter of 2022 was $2.0 million and relates to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong. The revenue for the fourth quarter of 2021 was immaterial.

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R&D Expenses: Research and development expenses were $3.1 million and $5.4 million in each of the three months ended March 31, 2022 and December 31, 2021, respectively. The changes are attributable to (i) decreases of $2.0 million for a license payment to Novo Nordisk for the completion of TTP399 phase 2 studies in Q4 2021, (ii) decreased severance costs of $0.7 million and payroll costs of $0.1 million in connection with the Company's restructuring plan that occurred in Q4 2021, (iii) decreased spending of $0.5 million related to the multiple ascending dose study for HPP737 offset by (iv) increases of $1.3 million due to manufacturing and analytical work related to chemistry manufacturing and control "CMC" for pivotal TTP399 studies, and the progression of TTP399 toxicology studies in Q1 2022.

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G&A Expenses: General and administrative expenses were consistent between periods at $5.3 million and $5.7 million for each of the three months ended March 31, 2022, and December 31, 2021. However, individual changes in the quarters are attributable to (i) lower payroll costs of $0.4 million and lower severance costs of $0.7 million due to the Company's restructuring plan that occurred in December 2021 and separation agreement with the Company's former CEO in Q1 2022, (ii) lower shared-based expense of $0.6 million due to the modification of awards related to the retirement and separation agreements with several key employees that occurred in Q4 2021, offset by (iii) higher other G&A operating costs of $0.2 million and (iv) increases of $1.1 million in legal expense.

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Other Income/(Expense): Other expense for the three months ended March 31, 2022, was $2.7 million and was driven by an unrealized loss related to the Company's investment in Reneo Pharmaceuticals, Inc. ("Reneo"), aswellas gains related to a reduction in the fairvalueoftheoutstandingwarrantsto purchase shares of our own stock issued to a related party ("Related Party Warrants"). Other income for the three months ended December 31, 2021, was $1.6 million and was driven by changes in the fair value of our investment in Reneo, aswell as the gains related to a reduction in fair value of the Related Party Warrants.

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Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.4 million for the first quarter of 2022 compared to net loss before non-controlling interest of $9.5 million for the fourth quarter of 2021. The decrease in net loss before Non-Controlling Interest was attributable to (i) increases in other expense of $4.3 million driven by changes in the fair value of our investment in Reneo, aswellas the gains related to a reduction in the fairvalueoftheoutstandingwarrantsto purchase shares of our own stock issued to a related party, offset by (ii) lower R&D expenses of $2.3 million, and (iii) higher revenue of $2.0 million due to an increase in the transaction price for a license performance obligation, that was fully recognized due to the satisfaction of a development milestone under the amended license agreement with Huadong.

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Net Loss Per Share: Diluted net loss per share was ($0.10) for the three months ended March 31, 2022 compared to diluted net loss per share of ($0.11) for the three months ended December 31, 2021, based on weighted-average diluted shares of 66.9 million and 66.8 million for the three-month periods ended March 31, 2022 and December 31, 2021, respectively.

March 31,

December 30,

2022

2021

(Unaudited)

Assets

Current assets:

Cash and cash equivalents

$

12,138

$

13,415

Accounts receivable

57

57

Prepaid expenses and other current assets

1,387

2,049

Current deposits

30

100

Total current assets

13,612

15,621

Property and equipment, net

255

278

Operating lease right-of-use assets

379

402

Long-term investments

5,939

9,173

Total assets

$

20,185

$

25,474

Liabilities, Redeemable Noncontrolling Interest and Stockholders' Deficit

Current liabilities:

Accounts payable and accrued expenses

$

12,474

$

8,023

Operating lease liabilities

191

184

Current portion of contract liabilities

35

35

Current portion of notes payable

-

256

Total current liabilities

12,700

8,498

Operating lease liabilities, net of current portion

441

492

Warrant liability, related party

770

1,262

Total liabilities

13,911

10,252

Commitments and contingencies

Redeemable noncontrolling interest

14,367

24,962

Stockholders' deficit:

Class A Common Stock

669

669

Class B Common Stock

232

232

Additional paid-in capital

238,669

238,193

Accumulated deficit

(247,663

)

(248,834

)

Total stockholders' deficit attributable to vTv Therapeutics Inc.

(8,093

)

(9,740

)

Total liabilities, redeemable noncontrolling interest and stockholders' deficit

$

20,185

$

25,474

Three Months Ended

March 31, 2022

December 31, 2021

Revenue

$

2,000

$

9

Operating expenses:

Research and development

3,133

5,402

General and administrative

5,348

5,716

Total operating expenses

8,481

11,118

Operating loss

(6,481

)

(11,109

)

Interest expense

(1

)

(6

)

Other (expense) income, net

(2,742

)

1,632

Loss before income taxes and noncontrolling interest

(9,224

)

(9,483

)

Income tax provision

200

-

Net loss before noncontrolling interest

(9,424

)

(9,483

)

Less: net loss attributable to noncontrolling interest

(2,417

)

(2,432

)

Net loss attributable to vTv Therapeutics Inc.

$

(7,007

)

$

(7,051

)

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(7,007

)

$

(7,051

)

Net loss per share of vTv Therapeutics Inc. Class A

Common Stock, basic and diluted

$

(0.10

)

$

(0.11

)

Weighted average number of vTv Therapeutics Inc.

Class A Common Stock, basic and diluted

66,942,777

66,785,550

Three Months Ended March 31,

2022

2021

(Unaudited)

Revenue

$

2,000

$

987

Operating expenses:

Research and development

3,133

3,103

General and administrative

5,348

2,164

Total operating expenses

8,481

5,267

Operating loss

(6,481

)

(4,280

)

Interest income

-

1

Interest expense

(1

)

-

Other expense, net

(2,742

)

(1,648

)

Loss before income taxes and noncontrolling interest

(9,224

)

(5,927

)

Income tax provision

200

15

Net loss before noncontrolling interest

(9,424

)

(5,942

)

Less: net loss attributable to noncontrolling interest

(2,417

)

(1,701

)

Net loss attributable to vTv Therapeutics Inc.

$

(7,007

)

$

(4,241

)

Net loss attributable to vTv Therapeutics Inc. common shareholders

$

(7,007

)

$

(4,241

)

Net loss per share of vTv Therapeutics Inc. Class A Common

Stock, basic and diluted

$

(0.10

)

$

(0.08

)

Weighted average number of vTv Therapeutics Inc. Class A

Common Stock, basic and diluted

66,942,777

56,472,535